US Regulatory Lead, Director- Immunology/Neurology
Company: Principia Biopharma Inc.
Posted on: June 7, 2021
The US Regulatory Affairs Lead is responsible for the proactive
development of innovative and robust US regulatory strategies for
pipeline and lifecycle assets in Sanofi's growing immunology and
neurology portfolios. He/she will be accountable for the efficient
and effective execution of US regulatory strategies while adhering
to US regulatory and company guidelines. The US RA Lead will serve
as Sanofi's liaison to the US FDA for assigned projects in clinical
development. In this role, he/she will lead the strategic
development of documentation submitted to the US FDA and lead FDA
meetings and negotiations. Further, the role represents the US GRA
perspective as a member of the project specific cross functional
global regulatory team (GRT). In this capacity, he/she will be
accountable to develop and maintain the US regulatory strategy
documents and advise on US regulatory issues at internal governance
meetings. In addition, the role prospectively works with the
labeling strategist and the GRT to develop US prescribing
information. The role works with and participates on
multi-disciplinary matrixed project teams to successfully meet
project deliverables while adhering to regulatory requirements for
programs and products. The role participates in the development and
monitoring of the US regulatory environment and updating of
standards and processes related to drug and biologics US
regulations. Lastly, the role may supervise and/or coach mentor,
junior staff supporting regulatory team.
Strategic thinker with an ability to make complex decisions and
willingness to defend difficult positions.
Solid knowledge and understanding of complex medical and
scientific subject matter as well as evolving US regulatory policy
Demonstrated experience with preparation of initial BLA, NDA, or
MAA, INDs, Health Authority meeting briefing documents.
Understanding of the development of drugs and/or innovative
Develops collaborative relationships to facilitate the
accomplishment of work goals.
Shows ability to use appropriate interpersonal styles and
techniques and can modify behavior to gain acceptance of ideas or
Excellent oral and written presentation skills.
Direct interaction/negotiation experience with US FDA.
Ability to work well within cross-functional globally oriented
Excellent time-management and operational skills including
planning, organizing and ability to motivate and lead others.
Ability to work in electronic document management systems.
Ability to build transversal networks to obtain cooperation
without relying on authority.
High standards of integrity.
- Organizational savvy; self-motivated and able to work in a
highly matrixed structure including sharing knowledge with relevant
At least 10 years' experience in drug development.
Solid working knowledge of drug development process and US
Demonstrated success developing and implementing regulatory
strategies for US INDs, BLA, and/or NDAs.
Experience with drug development in the field of immunology
and/or neurology, preferred.
Demonstrated experience successfully operating in a global
Advanced scientific degree preferred. B.A./B.S. or higher degree
(s) in the sciences, or health related field, minimum 8 years
regulatory strategy experience.
- Regulatory Certification (RAC) (optional) Fluent English
required; additional languages desirable.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and
Affirmative Action employers committed to a culturally diverse
workforce. All qualified applicants will receive consideration for
employment without regard to race; color; creed; religion; national
origin; age; ancestry; nationality; marital, domestic partnership
or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we
operate and embedded in our Core Values. We recognize to truly tap
into the richness diversity brings we must lead with inclusion and
have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for
Keywords: Principia Biopharma Inc., Cambridge , US Regulatory Lead, Director- Immunology/Neurology, Other , Cambridge, Massachusetts
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